Clavis Pharma ASA has announced the results of the LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CP-4126 (also known as CO-101), versus gemcitabine in metastatic pancreatic cancer.

The trial, which was conducted by partner Clovis Oncology, Inc., showed that there was no difference in overall survival between the two arms in either the primary analysis of the hENT1-low patient population, or in the overall intent-to-treat population.

Median survival in each arm was approximately six months with a hazard ratio of 0.99, and is consistent with the survival results from other gemcitabine studies in metastatic pancreatic cancer.

Adverse events were comparable between the two arms, and no differences were observed in any subgroup analyses.

Contrary to the results of numerous published retrospective studies, the study demonstrated that hENT1 status had no impact on survival for patients with metastatic pancreatic cancer treated with gemcitabine.

All development work with CP-4126 across all indications is now suspended by both Clavis Pharma and Clovis Oncology.

Clavis Pharma will continue to focus on elacytarabine and its CLAVELA Phase III study in patients with acute myeloid leukaemia (AML) who have failed prior therapy.

Recruitment into this study is expected to complete in Q4 2012 and top-line data are expected in Q1 2013.

Data from a Phase II study completed in 2009 and interim results from an elacytarabine/idarubicin combination study completed in 2012 highlight the promising efficacy and safety profile of elacytarabine in AML patients seen to date.

The final results of the combination study are due to be reported next month at the American Society of Haematology meeting in Atlanta, USA (8-11 December).

Olav Hellebø, Clavis Pharma CEO, said: “The results from the LEAP study are surprising and disappointing given the evidence we have seen from previous studies reported in the literature. This is bad news for patients who suffer from metastatic pancreatic cancer, which is a very difficult condition to treat. Meanwhile, we continue to believe in the potential of elacytarabine, our lead product, to become an effective new treatment option for acute myeloid leukaemia. We remain focused on completing the ongoing clinical trials in which elacytarabine is being investigated and in particular look forward to reporting the results from the pivotal Phase III CLAVELA study in the first quarter of 2013.”

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